Recall Z-0032-2012 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Inc.
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
| Date | Oct 7, 2011 (initiated Sep 1, 2011) |
| Status | Terminated |
| Reason | Clinical measurements on true size printouts may be inaccurate |
| Root cause | Software design |
| Action | Philips Medical notified all affected customers with a "Field Safety Notice" dated August 2011. The letter provides instructions to the customer for how to avoid the problem. Customers are informed that until the software upgrade is recieved from Philip, do not use the true-size printing feature if the system is configured for more than one DICOM printer. Customers will be instructed that they will receive a software upgrade when it is available. For questions on this recall contact Philips representative at (800) 722-9377. |
| Quantity | 20 units |
| Distribution | Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072960 | CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET Cdp, Ltd., Nov 8, 2007 |